Combunox (Oral)

Oxycodone hydrochloride/ibuprofen has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of oxycodone hydrochloride/ibuprofen, especially in children, can result in fatal overdose of oxycodone hydrochloride and ibuprofen. Prolonged use of oxycodone hydrochloride/ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use of cytochrome P450 3A4 inhibitors or discontinuation of concomitantly used cytochrome P450 3A4 inducers may affect the plasma levels of oxycodone and lead to increased adverse reactions and fatal respiratory depression. Monitor patients carefully when oxycodone hydrochloride/ibuprofen and cytochrome P450 3A4 inhibitors and inducers are concurrently used. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Oxycodone hydrochloride/ibuprofen is contraindicated for use in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also increase the risk of serious gastrointestinal (GI) adverse events (eg, bleeding, ulceration, and perforation of the stomach or intestines) especially in the elderly and patients with a prior history of ulcer disease and/or GI bleeding, which can be fatal .

Uses For Combunox

Ibuprofen and oxycodone combination is used to relieve acute, moderate to severe pain.

Ibuprofen is a nonsteroidal antiinflammatory drug (NSAID) that is used to relieve inflammation, swelling, and pain. Oxycodone is a narcotic analgesic that acts in the central nervous system to relieve pain. If oxycodone is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when you stop taking the medicine. Since ibuprofen and oxycodone combination is only used for short-term (7 days or less) relief of pain, physical dependence probably will not occur.

This medicine is available only with your doctor's prescription.

Before Using Combunox

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen and oxycodone combination in children younger than 14 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and ibuprofen combination in the elderly. However, elderly patients who may be more sensitive than younger adults to the effects of ibuprofen and oxycodone combination, are more likely to have kidney, lung, or stomach problems, which may require caution in patients receiving oxycodone and ibuprofen combination.

Pregnancy

Pregnancy Category

Explanation

1st Trimester

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

2nd Trimester

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

3rd Trimester

D

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Ketorolac

Nalmefene

Naltrexone

Safinamide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Abiraterone

Aceclofenac

Acemetacin

Acenocoumarol

Acepromazine

Alfentanil

Almotriptan

Alprazolam

Alvimopan

Amiloride

Amineptine

Amiodarone

Amisulpride

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Amprenavir

Amtolmetin Guacil

Anagrelide

Anileridine

Apixaban

Aprepitant

Ardeparin

Argatroban

Aripiprazole

Armodafinil

Asenapine

Aspirin

Atazanavir

Baclofen

Balsalazide

Bemiparin

Bendroflumethiazide

Benperidol

Benzhydrocodone

Benzphetamine

Benzthiazide

Betamethasone

Betrixaban

Bismuth Subsalicylate

Bivalirudin

Boceprevir

Bosentan

Bromazepam

Bromfenac

Bromopride

Brompheniramine

Budesonide

Bufexamac

Bumetanide

Buprenorphine

Buspirone

Butabarbital

Butorphanol

Cangrelor

Carbamazepine

Carbinoxamine

Carisoprodol

Carphenazine

Celecoxib

Ceritinib

Certoparin

Chloral Hydrate

Chlordiazepoxide

Chlorothiazide

Chlorpheniramine

Chlorpromazine

Chlorthalidone

Chlorzoxazone

Choline Magnesium Trisalicylate

Choline Salicylate

Cilostazol

Ciprofloxacin

Citalopram

Clarithromycin

Clobazam

Clomipramine

Clonazepam

Clonixin

Clopamide

Clopidogrel

Clorazepate

Clozapine

Cobicistat

Cocaine

Codeine

Conivaptan

Cortisone

Crizotinib

Cyclobenzaprine

Cyclopenthiazide

Cyclosporine

Dabigatran Etexilate

Dalteparin

Danaparoid

Darunavir

Deflazacort

Delavirdine

Desipramine

Desirudin

Desmopressin

Desvenlafaxine

Dexamethasone

Dexibuprofen

Dexketoprofen

Dexmedetomidine

Dextroamphetamine

Dextromethorphan

Dezocine

Diazepam

Diazoxide

Dibenzepin

Dichloralphenazone

Diclofenac

Difenoxin

Diflunisal

Digoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Dipyridamole

Dipyrone

Dolasetron

Donepezil

Dothiepin

Doxepin

Doxylamine

Dronedarone

Droperidol

Droxicam

Duloxetine

Edoxaban

Efavirenz

Eletriptan

Enflurane

Enoxaparin

Enzalutamide

Eplerenone

Epoprostenol

Eptifibatide

Erythromycin

Escitalopram

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethacrynic Acid

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etodolac

Etofenamate

Etoricoxib

Etravirine

Felbinac

Fenoprofen

Fentanyl

Fepradinol

Feprazone

Feverfew

Flibanserin

Floctafenine

Fluconazole

Flufenamic Acid

Fluocortolone

Fluoxetine

Fluphenazine

Flurazepam

Flurbiprofen

Fluspirilene

Fluvoxamine

Fondaparinux

Fosamprenavir

Fosaprepitant

Fosphenytoin

Fospropofol

Frovatriptan

Furazolidone

Furosemide

Ginkgo

Gossypol

Granisetron

Halazepam

Haloperidol

Halothane

Heparin

Hexobarbital

Hydrochlorothiazide

Hydrocodone

Hydrocortisone

Hydroflumethiazide

Hydromorphone

Hydroxytryptophan

Hydroxyzine

Ibuprofen

Idelalisib

Iloprost

Imatinib

Imipramine

Indapamide

Indinavir

Indomethacin

Iproniazid

Isocarboxazid

Isoflurane

Itraconazole

Ivacaftor

Ketamine

Ketazolam

Ketobemidone

Ketoconazole

Ketoprofen

Lanreotide

Lepirudin

Levomilnacipran

Levorphanol

Linezolid

Lisdexamfetamine

Lithium

Lofepramine

Lomitapide

Lopinavir

Lorazepam

Lorcaserin

Lornoxicam

Loxapine

Loxoprofen

Lumacaftor

Lumiracoxib

Magnesium Salicylate

Meadowsweet

Meclizine

Meclofenamate

Mefenamic Acid

Melitracen

Meloxicam

Melperone

Meperidine

Mephobarbital

Meprobamate

Meptazinol

Mesalamine

Mesoridazine

Metaxalone

Methadone

Methamphetamine

Methdilazine

Methocarbamol

Methohexital

Methotrexate

Methotrimeprazine

Methyclothiazide

Methylene Blue

Methylnaltrexone

Methylprednisolone

Metoclopramide

Metolazone

Mibefradil

Midazolam

Mifepristone

Milnacipran

Mirtazapine

Mitotane

Moclobemide

Modafinil

Molindone

Moricizine

Morniflumate

Morphine

Morphine Sulfate Liposome

Nabumetone

Nadroparin

Nafcillin

Nalbuphine

Nalorphine

Naloxone

Naproxen

Naratriptan

Nefazodone

Nelfinavir

Nepafenac

Nevirapine

Nialamide

Nicomorphine

Niflumic Acid

Nilotinib

Nimesulide

Nimesulide Beta Cyclodextrin

Nitrazepam

Nitrous Oxide

Nortriptyline

Olanzapine

Olsalazine

Ondansetron

Opipramol

Opium

Opium Alkaloids

Orphenadrine

Oxaprozin

Oxazepam

Oxcarbazepine

Oxymorphone

Oxyphenbutazone

Palbociclib

Palonosetron

Papaveretum

Paramethasone

Parecoxib

Paregoric

Parnaparin

Paroxetine

Pemetrexed

Pentazocine

Pentobarbital

Pentosan Polysulfate Sodium

Pentoxifylline

Perampanel

Perazine

Periciazine

Perphenazine

Phenelzine

Phenindione

Phenobarbital

Phenprocoumon

Phenylbutazone

Phenyl Salicylate

Phenytoin

Piketoprofen

Pimozide

Piperacetazine

Pipotiazine

Piritramide

Piroxicam

Polythiazide

Posaconazole

Pralatrexate

Prasugrel

Prazepam

Prednisolone

Prednisone

Primidone

Procarbazine

Prochlorperazine

Proglumetacin

Promazine

Promethazine

Propofol

Propyphenazone

Proquazone

Protein C

Protriptyline

Quazepam

Quetiapine

Ramelteon

Ranitidine

Ranolazine

Rasagiline

Reboxetine

Remifentanil

Remoxipride

Reviparin

Ribociclib

Rifabutin

Rifampin

Rifapentine

Ritonavir

Rivaroxaban

Rizatriptan

Rofecoxib

Salicylamide

Salicylic Acid

Salsalate

Samidorphan

Saquinavir

Secobarbital

Selegiline

Sertindole

Sertraline

Sibutramine

Sodium Oxybate

Sodium Salicylate

Spironolactone

Sufentanil

Sulfasalazine

Sulindac

Sulpiride

Sumatriptan

Suvorexant

Tacrolimus

Tapentadol

Telaprevir

Telithromycin

Temazepam

Tenofovir Disoproxil Fumarate

Tenoxicam

Thiethylperazine

Thiopental

Thiopropazate

Thioridazine

Tianeptine

Tiaprofenic Acid

Ticagrelor

Ticlopidine

Tilidine

Tinzaparin

Tirofiban

Tizanidine

Tolfenamic Acid

Tolmetin

Tolonium Chloride

Topiramate

Torsemide

Tramadol

Tranylcypromine

Trazodone

Treprostinil

Triamterene

Triazolam

Trichlormethiazide

Trifluoperazine

Trifluperidol

Triflupromazine

Trimeprazine

Trimipramine

Trolamine Salicylate

Tryptophan

Valdecoxib

Venlafaxine

Verapamil

Vilazodone

Vorapaxar

Voriconazole

Vortioxetine

Warfarin

Xipamide

Zaleplon

Ziprasidone

Zolmitriptan

Zolpidem

Zopiclone

Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alacepril

Amikacin

Atenolol

Azilsartan

Azilsartan Medoxomil

Benazepril

Betaxolol

Bisoprolol

Candesartan

Captopril

Carteolol

Carvedilol

Celiprolol

Cilazapril

Delapril

Enalapril

Enalaprilat

Eprosartan

Esmolol

Fosinopril

Imidapril

Irbesartan

Labetalol

Levobunolol

Lisinopril

Losartan

Metipranolol

Metoprolol

Moexipril

Nadolol

Nebivolol

Olmesartan

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Practolol

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

St John's Wort

Telmisartan

Temocapril

Timolol

Trandolapril

Valsartan

Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.

Proper Use of Combunox

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For pain:

Adults and children 14 years of age and older—1 tablet every 4 to 6 hours as needed. However, the dose is usually not more than 4 tablets per day, and should not be taken for longer than 7 days, unless directed by your doctor.

Children and children younger than 14 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Combunox

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Your doctor will want to check your blood pressure at the beginning of treatment and monitor it throughout treatment with this medicine. If high blood pressure occurs or worsens while taking this medicine, it may lead to serious heart problems.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs.

Ibuprofen and oxycodone combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicine, or other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause bleeding in your stomach or intestines. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). These problems can occur at any time with or without warning, and can be fatal. You should contact your doctor immediately if any of the following symptoms occur including black, tarry stools, bloody stools, vomiting of blood or material that looks like coffee grounds, severe or continuing stomach pain, cramping, or burning, trouble breathing, severe or continuing nausea, heartburn and/or indigestion.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded. If these reactions are especially bothersome, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when getting up suddenly from a lying or sitting position. Getting up slowly may lessen this problem.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Ibuprofen and oxycodone combination may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

If you have heart disease or congestive heart failure (CHF), tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Combunox Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Feeling faint, dizzy, or lightheaded

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

headache

sweating

Rare

Abdominal or stomach pain

blurred vision

changes in skin color

chest pain

confusion

convulsions

decrease in frequency of urination

decreased urine

difficulty in passing urine (dribbling)

difficulty with breathing

dizziness

dizziness, faintness, or lightheadedness when getting up from a lying position

dry mouth

excessive muscle tone

fainting

fast, pounding, or irregular heartbeat or pulse

increased need to urinate

increased thirst

loss of appetite

mood changes

muscle pain or cramps

muscle stiffness

muscle tension or tightness

nausea or vomiting

numbness or tingling in the hands, feet, or lips

pain, tenderness, or swelling of the foot or leg

painful urination

pale skin

passing urine more often

severe constipation

severe vomiting

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Change in consciousness

chest pain or discomfort

cold and clammy skin

constricted pupils

continuing ringing or buzzing or other unexplained noise in the ears

decreased awareness or responsiveness

difficult or troubled breathing

difficulty with sleeping

disorientation

drowsiness to profound coma

fainting

hearing loss

irregular, fast or slow, or shallow breathing

lethargy

loss of bladder control

loss of consciousness

muscle spasm or jerking of all extremities

pale or blue lips, fingernails, or skin

seeing, hearing, or feeling things that are not there

severe sleepiness

skeletal muscle flaccidity

sleepiness or unusual drowsiness

sudden fainting

sudden loss of consciousness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

belching

bloated or full feeling

diarrhea

difficulty having a bowel movement (stool)

excess air or gas in the stomach or intestines

fever

heartburn

indigestion

lack or loss of strength

passing gas

stomach discomfort, upset, or pain

Rare

Back pain

body aches or pain

bruising, large, flat, blue or purplish patches in the skin

changes in vision

chills

congestion

cough or hoarseness

delusions

dementia

difficult urination

difficulty with moving

dryness or soreness of the throat

enlarged abdomen or stomach

false or unusual sense of well-being

fear

hoarseness

impaired vision

increase in body movements

lower back or side pain

nervousness

pain, swelling, or redness in the joints

rash

runny nose

swelling

taste perversion

tender, swollen glands in the neck

trouble with sleeping

trouble with swallowing

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.